BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇺🇸 United States

    ACCORDE(R) IRRIGATING SYRINGE/PROCEDURE TRAY

    K Number: K904158 · Decision Nov 29, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    59
    Applicant Total
    8
    Review Days
    83

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    Basic Information

    Device Name
    ACCORDE(R) IRRIGATING SYRINGE/PROCEDURE TRAY
    K Number
    K904158
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Applicant
    Welcon, Inc.
    Date Received
    September 7, 1990
    Decision Date
    November 29, 1990
    Product Code
    FCM
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)

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    Other Clearances by Welcon, Inc.

    K Number Device Name
    K003402 WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION
    K973734 STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATION
    K971764 WELCON HUE-VU URINARY DRAINAGE BAG
    K912869 WOMEN AND INFANT'S DELIVERY PACK
    K894397 WELCON LIGHT HANDLE
    K830359 STERILE CATHERIZATION PROCEDURE TRAYS
    K813027 STERILE IRRIGATING SYRINGES, KITS,TRAY